BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SURGISMOKE

    K Number: K896822 · Decision Jan 11, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    74
    Applicant Total
    2
    Review Days
    38

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    Basic Information

    Device Name
    SURGISMOKE
    K Number
    K896822
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5070
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Spectro Industries, Inc.
    Date Received
    December 4, 1989
    Decision Date
    January 11, 1990
    Product Code
    FYD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FYD Apparatus, Exhaust, Surgical

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    Other Clearances by Spectro Industries, Inc.

    K Number Device Name
    K843433 KANIEVSKI SENSORY AID OR DEVICE